MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr ".It is unknown where the problem occurred.However, patient use information was requested but no additional information was provided.
Additional Manufacturer Narrative
The device associated with this complaint has been received, however, the investigation is pending.A follow-up report will be filed when the investigation has been completed.
Additional Manufacturer Narrative
The customer's reported complaint of the autopulse platform (sn (b)(6) displayed "system error, out of service, revert to manual cpr" error message" was confirmed during the functional testing and based on the archive data review.The root cause for the system error was due to the defective processor board, as a result of the normal wear and tear of the platform.The autopulse platform is a reusable device and was manufactured in february 2014 and is almost 8 years old, beyond the expected service life of 5 years.Upon visual inspection, unrelated to the reported complaint, noticed a head restraint wire was cut.The patient head restraint wire could have been cut to free the patient from the platform or the user could have been lifting the platform by holding the head restraints.Missing head restraints do not render the autopulse platform non-functional.The noted physical damage to the top cover appeared to be the characteristic of user mishandling.In addition, unrelated to the reported complaint, the top cover was observed cracked.This physical damage was likely due to user mishandling, such as a drop.The top cover needs to be replaced to address the damages.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering up the device.Therefore, the reported complaint was confirmed.The defective processor board (pca) needs to be replaced to remedy the fault.The archive data review showed the occurrence of system error - user advisory (ua) 132 (internal watchdog timeout) on the customer's reported event date, thus confirming the reported complaint.Waiting for customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(6).

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13083218
• Report Number: 3010617000-2021-01219
• Device Sequence Number: 12092110
• Product Code: DRM
• UDI-Device Identifier: 00849111000574
• UDI-Public: 00849111000574
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/24/2021
• Supplement Report FDA Received Date: 01/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown